Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01386333
• Date of registration: 29/06/2011
• Prospective Registration: No
• Primary sponsor: Lawson Health Research Institute
• Public title: Safety Study of Intranasal Oxytocin in Frontotemporal Dementia FTDOXY10EF
• Scientific title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
• Date of first enrolment: June 2011
• Target sample size: 23
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01386333
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Elizabeth C Finger, MD
• Affiliation: University of Western Ontario, Lawson Health Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 30-80 years

- Meets "Neary criteria" for diagnosis of probable frontotemporal dementia

- Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia

- Provides written informed consent and has a caregiver or legally acceptable
representative who provides written informed consent.

Exclusion Criteria:

- Has a history of a myocardial infarction within the last two years or congestive
heart failure.

- Current uncontrolled hypertension

- Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)

- Current hyponatremia

- Current use of prostaglandin medications

- Females who are pregnant or breastfeeding

- Use of any investigational or experimental drug or device within the last 60 days
prior to screening or within 5 half-lives of the experimental drug , whichever is
longer.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Intervention(s)

Drug: Saline Nasal Mist

Drug: oxytocin

Primary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 2 week]

Secondary Outcome(s)

Frontal Behavioural Inventory [Time Frame: 1 week]

Clinical Dementia Rating- Frontotemporal Lobar Degeneration [Time Frame: 1 week]

Interpersonal Reactivity Index [Time Frame: 1 week]

Multi-faceted Empathy Test [Time Frame: 1 week]

Neuropsychiatric Inventory [Time Frame: 1 week]

Clinicians Global Impression of Change [Time Frame: 1 week]

Secondary ID(s)

17783

R-11-232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)